CARBAMAZEPINE

Product NDC
62332-731
11-digit product format
623320731
Labeler code
62332
Product ID
62332-731_efc63831-b91e-492e-a499-1ed60db54018
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA216623
Marketing category
ANDA
Marketing start
2024-12-31
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CARBAMAZEPINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308979

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-731-10CARBAMAZEPINE100 in 1 CARTONTABLET1005
62332-731-10CARBAMAZEPINE10 in 1 BLISTER PACKTABLET105
62332-731-31CARBAMAZEPINE100 in 1 BOTTLETABLET1005
62332-731-60CARBAMAZEPINE60 in 1 BOTTLETABLET605
62332-731-91CARBAMAZEPINE1000 in 1 BOTTLETABLET10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-731CARBAMAZEPINE TABLET [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, 5 package rows20250424_87d343a8-84d5-4cdd-b0a0-629311b51f11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN87d343a8-84d5-4cdd-b0a0-629311b51f115
308979carbamazepine 200 MG Oral TabletSCD87d343a8-84d5-4cdd-b0a0-629311b51f115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-731-1062332073110100 BLISTER PACK in 1 CARTON (62332-731-10) / 10 TABLET in 1 BLISTER PACK100 blister pack2025-04-22NoNoCurrent
62332-731-3162332073131100 TABLET in 1 BOTTLE (62332-731-31) 100 tablet2025-04-22NoNoCurrent
62332-731-606233207316060 TABLET in 1 BOTTLE (62332-731-60) 60 tablet2025-04-22NoNoCurrent
62332-731-91623320731911000 TABLET in 1 BOTTLE (62332-731-91) 1000 tablet2025-04-22NoNoCurrent